A Safety and PK Study of EC-18 in Healthy Subjects

This will be a randomized, double-blind, placebo-controlled study of the safety,
tolerability, PK, and pharmacodynamics of single ascending doses of EC-18 or placebo. If no
dose limiting toxicity (DLT) is observed in Cohort One, the dose of EC-18 will be increased
to in Cohorts Two, Three, and Four, respectively. Dose escalation to each successive cohort
of subjects will not occur until a review of the safety and tolerability data from the
previous cohort is completed and the Investigator, Sponsor, and study Medical Monitor
together confirm the safety and tolerability of EC-18 given at that dose level.

Inclusion Criteria:

- Females of childbearing potential must use an acceptable birth control method
throughout the study and for 14 days after the dose of study drug.

- Females of non-childbearing potential (defined as surgically sterilized [tubal
ligation/hysterectomy/bilateral salpingo-oophorectomy] or postmenopausal for >2 years)
with a negative urine human chorionic gonadotropin pregnancy test at the Screening
Visit.

- Males willing to practice contraception (condom + spermicide) during the study and for
14 days after completion of the study, or who have a female partner using barrier or
oral contraception during that timeframe.

- Body mass index (BMI) between 18 and 32 kg/m2, inclusive.

- Ability to understand and give informed consent and provide authorization for use of
protected health information (Health Insurance Portability and Accountability Act).

- Willing and able to be confined to the research clinic as required by the protocol.

Exclusion Criteria:

- Febrile (temperature ≥99.5°F/37.5°C) at the Screening Visit or at admission to the
research clinic on Day -1.

- Clinically significant laboratory findings at the Screening Visit defined as the
following:

- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin >1.5
x upper limit of normal (ULN)

- Blood urea nitrogen (BUN), creatinine >1.25 x ULN

- White blood cell (WBC) count <0.9 x lower limit of normal (LLN) or >1.1 x ULN

- Hemoglobin or hematocrit <0.9 x LLN or >1.1 x ULN

- Platelet count <0.9 x LLN or >1.1 x ULN

- Glucose <0.9 x LLN or >1.25 x ULN

- Thyroid-stimulating hormone (TSH) <0.75 x LLN or >1.25 x ULN or any other
laboratory, ECG, vital sign, or physical abnormality that, in the investigator's
opinion, unfavorably increases the risk of study participation.

- Positivity for human immunodeficiency virus (HIV) or receiving active antiretroviral
therapy, hepatitis B surface antigen positivity, or hepatitis C positivity.

- History of drug or alcohol abuse within the past 2 years.

- Females who are pregnant or intend to get pregnant over the next month.

- Positive urine pregnancy test at the Screening Visit or at admission to the research
clinic on Day -1.

- Positive urine drug or breath alcohol test at the Screening Visit or at admission to
the research clinic on Day -1. Subjects should be instructed not to drink alcohol
within 12 hours of the screening assessment.

- Intake of alcohol within 72 hours prior to study drug administration or intake of
grapefruit or Seville oranges within 7 days prior to the administration of study drug.

- Strenuous physical exercise within 48 hours prior to study drug administration.

- Administration of any over-the-counter medication, dietary supplements, or vitamins
within 7 days prior to study drug administration. Excluded from this list is nondaily
use of acetaminophen at doses of ≤2 grams over a 24-hour period.

- Administration of prescription drugs or herbal supplements within 14 days prior to
study drug administration.

-.Exposure to any investigational agent within 30 days prior to the Screening Visit.

- Any current medical illness, signs, or symptoms that, in the investigator's opinion,
could adversely affect subject safety or study integrity.